A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer
- Conditions
- Urinary Bladder NeoplasmsMuscle-Invasive Bladder Cancer
- Interventions
- Registration Number
- NCT03661320
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to compare nivolumab plus neoadjuvant gemcitabine/cisplatin (GC) chemotherapy, followed by post-surgery continuation of immuno-oncology (IO) therapy, with neoadjuvant GC chemotherapy alone in adult participants with previously untreated muscle-invasive bladder cancer (MIBC).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 855
- Participant must be deemed eligible for Radial Cystectomy (RC) by his/her oncologist and/or urologist, and must agree to undergo Radial Cystectomy (RC) after completion of neoadjuvant therapy.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Clinical evidence of positive lymph node(s) (LN) (≥ 10 mm in short axis) or metastatic bladder cancer
- Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than trans urethral resection of bladder tumor (TURBT) or biopsies is also not permitted
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B: Nivolumab + GC Chemotherapy Nivolumab - Arm B: Nivolumab + GC Chemotherapy Cisplatin - Arm A: Gemcitabine/Cisplatin (GC) Chemotherapy Cisplatin - Arm A: Gemcitabine/Cisplatin (GC) Chemotherapy Gemcitabine - Arm B: Nivolumab + GC Chemotherapy Gemcitabine -
- Primary Outcome Measures
Name Time Method Pathological Complete Response (pCR) rate, in all randomized participants Approximately 43 months Arm B vs. Arm A
Event-Free Survival (EFS), in all randomized participants Approximately 36 months Arm B vs. Arm A
- Secondary Outcome Measures
Name Time Method EFS, descriptively in all concurrently randomized participants Approximately 36 months Arm C vs. Arm B and Arm A
OS, descriptively in all concurrently randomized participants Approximately 60 months Arm C vs. Arm B and Arm A
Overall Survival (OS) in all randomized participants Approximately 60 months Arm B vs. Arm A
Incidence of Adverse Events (AE) in participants who received at least one treatment dose Approximately 60 months Incidence of Serious Adverse Events (SAE) in participants who received at least one treatment dose Approximately 60 months Incidence of deaths in participants who received at least one treatment dose Approximately 60 months Incidence of laboratory abnormalities in participants who received at least one treatment dose Approximately 60 months pCR rate, descriptively in all concurrently randomized participants Approximately 43 months Arm C vs. Arm B and Arm A
Trial Locations
- Locations (171)
Local Institution - 0022
🇺🇸Tucson, Arizona, United States
UC Davis Comprehensive Cancer Center
🇺🇸Sacramento, California, United States
Local Institution - 0021
🇺🇸Littleton, Colorado, United States
Local Institution - 0036
🇺🇸Pensacola, Florida, United States
Local Institution - 0004
🇺🇸Tampa, Florida, United States
Local Institution - 0144
🇺🇸Atlanta, Georgia, United States
Local Institution - 0005
🇺🇸Chicago, Illinois, United States
Local Institution - 0006
🇺🇸Peoria, Illinois, United States
Local Institution - 0181
🇺🇸Columbia, Maryland, United States
Local Institution - 0009
🇺🇸Boston, Massachusetts, United States
Scroll for more (161 remaining)Local Institution - 0022🇺🇸Tucson, Arizona, United States